A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
Purpose
The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.
Condition
- Hereditary Angioedema
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions: - Completed STAR-0215-201 (follow up through 6 months after their last dose); - Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks; - Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or - Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor). - Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).
Exclusion Criteria
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria. - Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening - Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening. - Use of therapies prescribed for the prevention of HAE attacks prior to Screening: - lanadelumab within 90 days - berotralstat within 21 days - all other prophylactic therapies, discuss with the Medical Monitor Note: Other inclusion and exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Regimen 1 (Arm A): STAR-0215 |
Participants will receive STAR-0215 every 3 months. |
|
|
Experimental Dose Regimen 2 (Arm B): STAR-0215 |
Participants will receive STAR-0215 every 6 months. |
|
|
Experimental Dose Regimen 1 (Arm C): STAR-0215 |
STAR-0215 will be administered as a subcutaneous injection. |
|
|
Experimental Dose Regimen 3 (Arm D): STAR-0215 |
STAR-0215 will be administered as a subcutaneous injection. |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Astria Therapeutics, Inc.